Dental AnxietyNCT06730425
Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures
An observational study of Dental Anxiety and Dental Fear, run by Midwestern University at 1 site in United States.
Trial summary
Pediatric patients are susceptible to show signs of fear. One of the scenarios that have always been a source of fear is undergoing a dental procedure. Fear of undergoing dental procedure has been addressed as "dental fear", which can lead to avoidance of receiving dental care and may result to a decline in proper… Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Dental Fear, Stress
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2024to 30 May 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: New pediatric patients that needs treatment at either the pediatric or the orthodontic departments of the dental institute at Midwestern University
Who may be able to join
- Children between the ages of 7 and 17
- Ability to read and speak English language
- Patients seen for a first visit at the pediatric or orthodontic departments of the dental institute of the Multispecialty Clinic at Midwestern University with a scheduled future appointment to start treatment in the pediatric or orthodontic department
Who cannot join
- Older than 17 years of age or younger than 7 years of age
- Unable to read and speak English language
- Have any major health conditions or history of mental illness
- Being a returning patient in the pediatric or orthodontic department of the dental institute of the Multispecialty Clinic at Midwestern University
- Taking any systemic medications that would cause a change in salivary flow (e.g., oxybutynin, protein pump inhibitors)
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwestern University
Downers Grove, Illinois, 60515
About this study
Official title: Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures. A Prospective Longitudinal Study
Pediatric patients are susceptible to show signs of fear. One of the scenarios that have always been a source of fear is undergoing a dental procedure. Fear of undergoing dental procedure has been addressed as "dental fear", which can lead to avoidance of receiving dental care and may result to a decline in proper oral hygiene.
Fear stimulates multiple cerebral responses and can be often related to an increased stress level. Stress level fluctuations during dental procedures can be examined by blood and salivary biomarkers. Given accessibility and minimal invasiveness, the collection of saliva samples constitutes an easy and cost-effective diagnostic method to investigate a variety of oral and systemic conditions. Cortisol and alpha amylase are present within the saliva and their levels are supposedly influenced by stress. In contrast, salivary IgA is not known to be influenced by stress level and can be used in comparison as a non-stress salivary biomarker.
Read more
Fear of dental appointments is a well-known cause of stress and activation of the sympathetic nervous system in adolescents undergoing dental procedure. However, the examination of stress and stress-related factors in young individuals attending their first dental appointment compared to young individuals who present for an orthodontic application is largely understudies.
Therefore, the aims of the study are: 1) to measure stress salivary biomarkers in pediatric patients before undergoing dental and/or orthodontic procedures; 2) assess whether subjective stress to dental treatment (as measured by dental anxiety, stress, and dental fear) is associated with objective stress measurements (as measured by collection of stress salivary biomarkers).
- Conditions
- Dental Anxiety, Dental Fear, Stress, Pediatric Population
- Keywords
- dental anxiety, pediatric patients, salivary biomarkers, salivary diagnostics, dental fear, stress, salivary cortisol, salivary alpha-amylase, salivary IgA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients seen at the pediatric or orthodontic department | New pediatric patients seen for the first time at either the pediatric or the orthodontic department at the dental clinic of Midwestern University to start either a dental procedure or an orthodontic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between psychological distress and levels of salivary biomarkers
Levels of dental fear (measured with 15-75 Children\'s Fear Survey Schedule-Dental Subscale, with values \>38 identifying dental fear), dental anxiety (measured with 8-40 Modified Child Dental Anxiety Scale, with values \>19 identifying anxiety) and self-perceived stress (measured with 1-40 Perceived Stress Scale, with values \>14 identifying stress) will be correlated with levels of salivary cortisol, alpha-amylase and IgA
Measured: At one time-point, before starting the dental procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start9 Sep 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06730425
- Sponsor's protocol ID
- CIRB#IL24015
- Status last verified
- Aug 2025
- First submitted
- 9 Dec 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures. A Prospective Longitudinal Study
- ClinicalTrials.gov ID
- NCT06730425
- Acronym / sponsor ID
- CIRB#IL24015
- Conditions
- Dental Anxiety, Dental Fear, Stress, Pediatric Population
- Keywords
- dental anxiety, pediatric patients, salivary biomarkers, salivary diagnostics, dental fear, stress, salivary cortisol, salivary alpha-amylase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric patients are susceptible to show signs of fear. One of the scenarios that have always been a source of fear is undergoing a dental procedure. Fear of undergoing dental procedure has been addressed as "dental fear", which can lead to avoidance of receiving dental care and may result to a decline in proper oral hygiene.
Fear stimulates multiple cerebral responses and can be often related to an increased stress level. Stress level fluctuations during dental procedures can be examined by blood and salivary biomarkers. Given accessibility and minimal invasiveness, the collection of saliva samples constitutes an easy and cost-effective diagnostic method to investigate a variety of oral and systemic conditions. Cortisol and alpha amylase are present within the saliva and their levels are supposedly influenced by stress. In contrast, salivary IgA is not known to be influenced by stress level and can be used in comparison as a non-stress salivary biomarker.
Fear of dental appointments is a well-known cause of stress and activation of the sympathetic nervous system in adolescents undergoing dental procedure. However, the examination of stress and stress-related factors in young individuals attending their first dental appointment compared to young individuals who present for an orthodontic application is largely understudies.
Therefore, the aims of the study are: 1) to measure stress salivary biomarkers in pediatric patients before undergoing dental and/or orthodontic procedures; 2) assess whether subjective stress to dental treatment (as measured by dental anxiety, stress, and dental fear) is associated with objective stress measurements (as measured by collection of stress salivary biomarkers).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients seen at the pediatric or orthodontic department | – | –New pediatric patients seen for the first time at either the pediatric or the orthodontic department at the dental clinic of Midwestern University to start either a dental procedure or an orthodontic treatment |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- New pediatric patients that needs treatment at either the pediatric or the orthodontic departments of the dental institute at Midwestern University
Key inclusion criteria (3 listed)
- Children between the ages of 7 and 17
- Ability to read and speak English language
- Patients seen for a first visit at the pediatric or orthodontic departments of the dental institute of the Multispecialty Clinic at Midwestern University with a scheduled future appointment to start treatment in the pediatric or orthodontic department
Key exclusion criteria (5 listed)
- Older than 17 years of age or younger than 7 years of age
- Unable to read and speak English language
- Have any major health conditions or history of mental illness
- Being a returning patient in the pediatric or orthodontic department of the dental institute of the Multispecialty Clinic at Midwestern University
- Taking any systemic medications that would cause a change in salivary flow (e.g., oxybutynin, protein pump inhibitors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between psychological distress and levels of salivary biomarkers
Time frame: At one time-point, before starting the dental procedure
Levels of dental fear (measured with 15-75 Children\'s Fear Survey Schedule-Dental Subscale, with values \>38 identifying dental fear), dental anxiety (measured with 8-40 Modified Child Dental Anxiety Scale, with values \>19 identifying anxiety) and self-perceived stress (measured with 1-40 Perceived Stress Scale, with values \>14 identifying stress) will be correlated with levels of salivary cortisol, alpha-amylase and IgA
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety and Dental Fear, run by Midwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between psychological distress and levels of salivary biomarkers (time frame: At one time-point, before starting the dental procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2025.